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Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.

NCT ID: NCT05401240

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-07-30

Brief Summary

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Exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Detailed Description

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Background: exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Hypothesis: cardiopulmonary exercise test (CPET) incentives ACS survivors to participate in outpatient cardiac rehabilitation.

Objectives: 200 ACS survivors who are eligible for cardiac rehabilitation will be allocated randomly into control and experimental groups.

Method: before discharge, both control and experimental groups will be informed of the importance of cardiac rehabilitation and invited to participate the outpatient rehabilitation. The experimental group will also be told that an important examination, i.e. the CPET, will be performed in order to evaluate their heart function at the outpatient department (OPD).

Primary outcome: the presence of ACS survivors at the OPD of rehabilitation in order to receive the rehabilitation/CPET.

Secondary outcomes: the adherence to cardiac rehabilitation, defined as completing a full course of cardiac rehabilitation (6 sessions) or home-based exercise.

Factors that might influence the presence of ACS survivors at OPD of rehabilitation will also be recorded and analyzed, including:

* Patient characteristics: age, sex, body mass index (BMI), cardiovascular disease (CVD) risk factors
* Electrocardiography (ECG): ST elevation myocardial infarction (STEMI) or non ST elevation myocardial infarction (NSTEMI)
* Lab data: peak troponin level.
* Days of hospitalization. Statistics: t-test, ANOVA

Conditions

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Acute Coronary Syndrome

Keywords

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cardiac rehabilitation cardiopulmonary exercise testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CEPT informed

the patient is informed and asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, as well as to take an important examination (cardiopulmonary exercise testing) for his/her cardiorespiratory fitness.

Group Type EXPERIMENTAL

information reveal

Intervention Type BEHAVIORAL

the experimental group will be informed that there will be an important examination about his/her cardiopulmonary fitness condition at the outpatient department (OPD)

CPET not informed

the patient is asked to returned to the outpatient department (OPD) in order to received cardiac rehabilitation, but not informed about the cardiopulmonary exercise testing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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information reveal

the experimental group will be informed that there will be an important examination about his/her cardiopulmonary fitness condition at the outpatient department (OPD)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* acute coronary patients

Exclusion Criteria

* acute illness that stayed in hospital for more than 2 weeks.
* patients who received surgical intervention
* severe complications (ex. respiratory failure, stroke, acute renal failure)
* contraindications of cardiopulmonary exercise testing
* patients who cannot perform the cardiopulmonary exercise testing
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuchun Lee, MD

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CE22225A

Identifier Type: -

Identifier Source: org_study_id